ADAC MODELS XL-PLAN 23 & XL-PLAN 73— 510(k) K851041

Substantially Equivalent

Adac Laboratories

FDA 510(k) clearance K851041 for ADAC MODELS XL-PLAN 23 & XL-PLAN 73, Substantially Equivalent on 1985-07-18. Applicant: Adac Laboratories. Device class: 2.

Clearance details

Applicant
Adac Laboratories
Product code
Code IYE
Device class
Class 2
Regulation
21 CFR 892.5050
Advisory panel
Radiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Jose, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code IYE

product code IYE
Malfunction
455
Other
3
Total
458

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.